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The use of polyethoxylated castor oils in prostaglandin compositions greatly enhances the prostaglandin's chemical stability.

Inventor(s):

Schneider; L. Wayne (Crowley, TX)

Assignee:

Alcon Laboratories, Inc. (Fort Worth, TX)

Application Number:

08/738,629

Patent Claims:

1. An aqueous pharmaceutical composition comprising a prostaglandin, a polyethoxylated castor oil in an amount effective to enhance the chemical stability of the
prostaglandin, an antimicrobial preservative and a pharmaceutically acceptable vehicle.

2. The composition of claim 1 wherein the polyethoxylated castor oil is present at a concentration between about 0.02 wt % and about 20.0 wt %.

3. The composition of claim 2 wherein the polyethoxylated castor oil is present at a concentration between about 0.1 wt % and about 5.0 wt %.

4. The composition of claim 3 wherein the polyethoxylated castor oil is present at a concentration between about 0.5 wt % and about 2.0 wt %.

5. The composition of claim 1 wherein the polyethoxylated castor oil is selected from the group consisting of: PEG-2 to PEG-200 castor oils and PEG-5 to PEG-200 hydrogenated castor oils.

6. The composition of claim 5 wherein the polyethoxylated castor oil is selected from the group consisting of: PEG-15 to PEG-50 castor oils.

7. The composition of claim 6 wherein the polyethoxylated castor oil is selected from the group consisting of: PEG-30 to PEG-35 castor oils.

10. The composition of claim 9 wherein the prostaglandin is selected from the group consisting of (5Z)-(9R,11R,15R)-9-chloro-15-cyclohexyl-11,15-dihydroxy-3-oxa-16,17,18,19 ,20-pentanor-5-prostenoic acid isopropyl ester and (5Z)-(9R,11R,15R
-9-chloro-15-cyclohexyl-11,15-dihydroxy-3-oxa-16,17,18,19,20-pentanor-5-pr ostenoic acid t-butyl ester.

11. The composition of claim 1 wherein the prostaglandin is present at a concentration between about 0.0001 wt % and about 0.1 wt %.

12. The composition of claim 1 wherein the composition is a topically administrable ophthalmic composition.

13. An method for the treatment of glaucoma and ocular hypertension, comprising the topical administration to an affected eye of an aqueous composition comprising a prostaglandin, a polyethoxylated castor oil, an antimicrobial preservative and
an ophthalmically acceptable vehicle, wherein the polyethoxylated castor oil is present in an amount effective to enhance the chemically stability of the prostaglandin.

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